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® 



® 



Europaisches Patentamt 
European Patent Office 
Office europeen des brevets 



© Publication number: 
EUROPEAN PATENT APPLICATION 



0 651 250 A2 



Application number: 94117146.4 


© int. Cl. B : G01N 33/49, A61B 5/00 


(22/ Date of filing: 29.10.94 




© Priority: 02.1 1. 93 JP 274228/93 


© Applicant: KYOTO DAIICHI KAGAKU CO., LTD. 


(«y Date of publication of application: 


57 NishiaKeta-cho 


Higashikujo 


03.05.95 Bulletin 95/18 


Minami-ku 


© Designated Contracting States: 


Kyoto-shi 


Kyoto-fu (JP) 


CH DE FR GB IT LI 






© Inventor: Hyodo, Hiroshi, c/o KYOTO DAIICHI 




KAGAKU CO., LTD. 




57, Nishiaketa-cho, 




Higashikujo, 




Minami-ku 




Kyoto-shi, 




Kyoto-fu (JP) 




© Representative: Dallmeyer, Georg et al 




Patentanwalte 




Von Kreisler-Selting-Werner 




Bahnhofsvorplatz 1 (Deichmannhaus) 




D-50667 Koln (DE) 



© Data managing method In portable blood sugar value-measuring and portable blood sugar 
value-measuring apparatus using same. 



© A managing method includes steps of selecting a function according to the type of an electrode mounted on 
the portable blood sugar value-measuring apparatus (step S4); executing a process of clocking a predetermined 
period of time (steps S6, S32, S42); deciding whether or not the clocking process has been switched over to a 
different process while the predetermined period of time is being clocked (steps S7, S31, S41); and reading out 
data of measured blood sugar values stored in a storing means from a termination point of the first 
predetermined period of time when the first predetermined period of time has terminated without the switch-over 
from the first clocking process to the blood sugar value-measuring process being decided in the deciding 
^ process (steps S8, S33, S43). 

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EP 0 651 250 A2 



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COMPLETION I ELECTROCE IS MOUNTED J ST 
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ALL DISPLAYS ARE TURNED 
ON FOR TWO SECONDS 

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CONTROL LIOUID 
CAN BE USED 



NEXT MEASUREMENT NUMBER 

AND T NUMBER ARE 
ALTERNATELY DISPLAYED 








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2 



EP 0 651 250 A2 



BACKGROUND OF THE INVENTION 
1. Field of the Invention 

s The present invention relates to a data managing method in a portable blood sugar value-measuring 
apparatus and the portable blood sugar value-measuring apparatus which carries out the data managing 
method. The method and the apparatus can be used by a patient himself/herself to measure his/her blood 
sugar value. 

io 2. Conventional Art 

People know a portable blood sugar value-measuring apparatus which stores data of blood sugar values 
sequentially measured by a diabetic for himself/herself. In reading out a plurality of the stored data of the 
measured blood sugar values in such a conventional blood sugar value-measuring apparatus, an operation 

75 button provided on the surface thereof is depressed to display them sequentially on a display portion. 

As disclosed in Japanese Laid-Open Patent Publication No. 357452/1992, the present applicant 
proposed a blood sugar value-measuring apparatus having no operation buttons provided thereon. In the 
blood sugar value-measuring apparatus disclosed in the Patent Publication, various types of electrodes 
such as a blood sugar value-measuring one, correcting one and the like having its own resistance value are 

20 installed on the blood sugar value-measuring apparatus. When one of them is mounted on the blood sugar 
value-measuring apparatus, its resistance value is detected and then, the blood sugar value-measuring 
apparatus is set to operation state. In addition, which type of the electrodes has been installed on the blood 
sugar value-measuring apparatus can be detected based on its resistance value. In this manner, a function 
of each type of electrode is performed in the blood sugar value-measuring apparatus. This construction 

25 eliminates the need for the provision of an operation switch. 

SUMMARY OF THE INVENTION 

An object of the present invention is to provide an improved data managing method which is used in a 
30 portable blood sugar value-measuring apparatus having no operation buttons in order to eliminate the 
provision of the operation on reading a plurality of measured blood sugar values and to provide the portable 
blood sugar value-measuring apparatus storing the measured blood sugar values in a storing means 
sequently, reading the measured blood sugar values from the storing means, or the like. 

In accomplishing the aforementioned object, according to one aspect of the present invention of the 
35 data managing method, there is provided a data managing method, to be carried out in a portable blood 
sugar value-measuring apparatus having no operation button, of selectively and removably mounting one of 
electrodes on the apparatus to execute a function in correspondence with a resistance value of the selected 
electrode, comprising: 

a preparatory process of mounting the electrode on the portable blood sugar value-measuring 
40 apparatus to set the apparatus to an operation start state and select the function to be executed in 
correspondence with the mounted electrode; 

a first clocking process of clocking a first predetermined period of time after the execution of the 
preparatory process terminates; 

a deciding process for deciding whether the first clocking process has been switched over to a blood 
45 sugar value-measuring process for measuring a blood sugar value of to-be-measured liquid which has 
dropped to the mounted electrode while clocking the first predetermined period of time is being executed in 
the first clocking process, a measured blood sugar value in the blood sugar value-measuring process is 
stored in a storing means when it is decided that the measured blood sugar value is to be stored in the 
storing means; and 

so a read-out process for reading out data stored in the storing means from a termination point of the first 
predetermined period of time and outputting the data read out from the storing means when the first 
predetermined period of time has terminated without the switch-over from the first clocking process to the 
blood sugar value-measuring process being decided in the deciding process. 

According to another aspect of the present invention of the apparatus, there is provided a portable 

55 blood sugar value-measuring apparatus, having no operation button, for selecting a function to be executed 
based on one of electrodes each of which has resistance value executing a function, the apparatus having 
an electrode detection means for detecting whether or not one of the electrodes removable therefrom has 
been mounted thereon, thus outputting a mounting detection signal; and a signal output means, connected 



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EP 0 651 250 A2 



with an output side of the electrode detection means, for outputting a function selection signal based on a 
resistance value of the electrode mounted on the portable blood sugar value-measuring apparatus, the 
apparatus comprising: 

a storing means for storing data of measured blood sugar values obtained by executing a blood sugar 
5 value-measuring function selected based on the resistance value of the mounted electrode; 

a preparatory means, connected with the output side of the electrode detection means and an output 
side of the signal output means, for setting the portable blood sugar value-measuring apparatus to an 
operation start state when the electrode detection means detects that the electrode has been mounted on 
the portable blood sugar value-measuring apparatus and selecting the function to be executed based on the 
w function selection signal; 

a first clocking means connected with an output side of the preparatory means, for clocking a first 
predetermined period of time from a point when the function is selected by the preparatory means; 

a deciding means, connected with an output side of the first clocking means, the output side of the 
electrode detection means, and the output side of the signal output means, for deciding whether or not the 
75 mounting detection signal and the function selection signal have been supplied while clocking the first 
predetermined period of time is being executed; and 

a read-out means, connected with the output side of the deciding means and an output side of the 
storing means, for reading out the data of the measured blood sugar values stored in the storing means 
from a point when the first predetermined period of time has terminated and outputting the data of the 
20 measured blood sugar values when the first predetermined period of time has terminated without the 
deciding means deciding whether or not the function selection signal has been supplied. 

By the above construction of the present invention, the deciding means decides whether or not the 
function selection signal has been supplied while the operation of counting the first predetermined period of 
time is being executed. If the deciding means decides that the function selection signal has not been 
25 supplied, the read-out means starts reading the data of the measured blood sugar values stored in the 
storing means when the first predetermined period of time has terminated. 

Accordingly, the preparatory means, the first clocking means, the deciding means, the read-out means, 
and the electrode detecting means act smoothly when the data of the measured blood sugar values is read 
out from the storing means. 

30 

BRIEF DESCRIPTION OF THE DRAWINGS 

These and other objects and features of the present invention will become clear from the following 
description taken in conjunction with the preferred embodiments thereof with reference to the accompany- 
35 ing drawings throughout which like parts are designated by like reference numerals, and in which: 

Fig. 1 is a flowchart showing the operation of a data managing method according to an embodiment of 
the present invention; 

Fig. 2 is a flowchart subsequent to the flowchart shown in Fig. 1 ; 
Fig. 3 is a flowchart subsequent to the flowchart shown in Fig. 2; 
40 Fig. 4 is a flowchart showing an embodiment of the operation of a measuring function to be executed by 
means of a testing electrode; 

Fig. 5 is a flowchart showing an embodiment of the operation of a correcting function; 
Fig. 6 is a view showing the display method of data of a blood sugar value stored in a RAM; 
Fig. 7 is a perspective view showing the outlook configuration of an example of a blood sugar value- 
45 measuring apparatus to which the data managing method of the present invention is applied; 

Fig. 8 is a block diagram showing an embodiment of the construction of the blood sugar value-measuring 
apparatus shown in Fig. 7; 

Fig. 9 is a block diagram showing the construction of a CPU shown in Fig. 8; 
Fig. 10 is a perspective view showing the electrode shown in Fig. 7; 
50 Fig. 11 is an exploded perspective view showing an electrode according to another embodiment of the 
present invention; 

Fig. 12 is an exploded perspective view showing an electrode according to still another embodiment of 
the present invention; and 

Fig. 13 is a perspective view showing the assembled electrode shown in Fig. 12. 



4 



EP 0 651 250 A2 
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 



Before the description of the present invention proceeds, it is to be noted that like parts are designated 
by like reference numerals throughout the accompanying drawings. 

5 A portable blood sugar value-measuring apparatus to which a data managing method according to an 
embodiment of the present invention does not have an operation switch, similarly to the blood sugar value- 
measuring apparatus disclosed in the Patent Publication previously described. The operation switch means 
a switch which is mounted on an outer surface of the blood sugar value-measuring apparatus and can be 
manually operated by a user. An example of the outline of the construction of the blood sugar value- 

10 measuring apparatus is described below. 

Referring to Fig. 7, the blood sugar vague-measuring apparatus 1 is rectangular and plate-shaped. 
There is formed on a side surface 1a of the blood sugar value-measuring apparatus 1 in the thickness 
direction thereof a connector 3 into which various electrodes 45 such as a measuring electrode 4 for 
measuring a blood sugar value as shown in Fig. 10 are inserted. A liquid crystal display (LCD) 2 occupying 

75 a large area of the upper surface 1b of the blood sugar value-measuring apparatus 1 is formed thereon. 

The circuit construction of the blood sugar value-measuring apparatus 1 is described below with 
reference to Fig. 8. 

A power battery 57 incorporated in the blood sugar value-measuring apparatus 1 is connected with a 
battery checking device 58 which decides whether the voltage of the power battery 57 is in a predeter- 

20 mined range. The output side of the battery checking device 58 is connected with a CPU 50. The power 
battery 57 is connected with the CPU 50 via a voltage stabilizing circuit 62, thus supplying the CPU 50 with 
a predetermined electric power. 

The connector 3 is connected with the input side of a detecting circuit 52 which detects whether or not 
the electrode 45 has been mounted on the connector 3, thus outputting a signal indicating that the electrode 

25 45 has been mounted on the connector 3 if the electrode 45 has been mounted thereon. The connector 3 is 
also connected with the input side of a current/voltage converter 53 for converting electric current flowing 
through the electrode 45 connected with the connector 3 into a voltage. The output side of the detecting 
circuit 52 is connected with the CPU 50 so that the detecting circuit 52 outputs a signal indicating that the 
electrode 45 has been mounted on the connector 3 to the CPU 50. The current/voltage converter 53 is 

30 connected with the output side of a reaction voltage setting circuit 63 connected with the output side of the 
voltage stabilizing circuit 62. The reaction voltage setting circuit 63 supplies a predetermined reaction 
voltage to the electrode 45 mounted on the connector 3 via the current/voltage converter 53, when the 
reaction voltage setting circuit 63 has been supplied with a control signal outputted from the CPU 50 upon 
receipt of a signal from the detecting circuit 52. The current/voltage converter 53 is connected with the 

35 output side of a gain control circuit 65, the input side of which is connected with the CPU 50. The output 
side of the current/voltage converter 53 is connected with the CPU 50 via an A/D converter 54. Thus, the 
intensity of electric current flowing through the electrode 45 is converted into a digital value and the digital 
value is supplied to the CPU 50 as data. 

The CPU 50 is connected with a RAM (random access memory) 70 for storing the data of blood sugar 

40 values measured by the measuring electrode 4. The RAM 70 can store the data of latest 10 measured 
blood sugar values and the data of measured values of control liquid which will be described later. 

The CPU 50 is also connected with the output side of a resetting circuit 64, the input side of which is 
connected with the output side of the voltage stabilizing circuit 62; the output side of a temperature sensor 
55; the output side of an oscillator 60 for outputting clock signals; the input side of the LCD 2; the input side 

45 of a buzzer 59 for generating an alarm; and the input and output sides of a semiconductor memory 61 for 
storing the correction value for each blood sugar value-measuring apparatus: 

The outline of the fundamental operation, similar to that disclosed in the above-described Patent 
Publication, of the blood sugar value-measuring apparatus 1 having the above construction is described 
below. 

so The main component contained in the reagent layer of the measuring electrode 4 consists of 
oxidoreductase having a substrate contained in biological body fluid and a redox compound serving as a 
substance for transporting electrons of the oxidoreductase. 

For example, the main component consists of glucose oxidase (hereinafter referred to as GOD) and 
potassium ferricyanide serving as mediator. When the electrode is supplied with measured liquid containing 

55 glucose, the mediator, namely, potassium ferricyanide and glucose react with each other in the presence of 
GOD as shown by an equation 1 shown below to form potassium ferrocyanide corresponding to the density 
of glucose. At a certain interval, an electric circuit is used in this embodiment to apply a certain voltage to 
both ends of a lead of the electrode. The intensity of oxidation current thus obtained is proportional to the 



5 



BP 0 651 250 A2 



density of potassium ferrocyanide formed by the reaction shown by the equation 1 , namely, the density of 
glucose. Thus, the density of glucose contained in the measured liquid can be measured by measuring the 
intensity of electric current generated by the application of the voltage to the electrode. 

5 [Equation 1] 

GOD 

D-Glucose + 2Fe{CN) 6 3 " + H 2 0 h> 

70 Gluconic acid + 2H + + 2Fe(CN) 6 4 ~ 

2Fe(CN) 6 4 " > 2Fe(CN) 6 3 ~ + 2e" 

constant voltage 

15 

First, the measuring electrode 4 is inserted into the connector 3. When the detecting circuit 52 has 
detected the insertion of the measuring electrode 4 into the connector 3, the reaction voltage setting circuit 
63 serving as the power supply applies a predetermined voltage necessary for obtaining response electric 
current to the terminal of the connector 3. Thus, the response electric current flowing through the measuring 

20 electrode 4 inserted into the connector 3 is converted into a voltage by the current/voltage converter 53 and 
then, the voltage is converted into binary data by the A/D converter 54. 

The CPU 50 reads an output signal of the A/D converter 54, thus executing processing. The measuring 
electrode 4 containing enzyme is considered to be a kind of a resistor. Supposing that the resistance value 
of the measuring electrode 4 is Rs; the amplification resistance of the current/voltage converter 53 is Rf; 

25 and a voltage to be applied to the terminal of the connector 3 is E, the output voltage Eo of the 
current/voltage converter 53 is found by the following equation: 

Eo = E + ixRf = E + (E/Rs) x Rf 

30 The resistance value Rs of the measuring electrode 4 is as great as an infinite quantity when the 
measuring electrode 4 is not supplied with to-be-measured liquid. Accordingly, the intensity (i) of electric 
current is very small and thus, the output voltage Eo of the current/voltage converter 53 is nearly equal to E. 

When the measuring electrode 4 is supplied with the to-be-measured liquid, the resistance value Rs of 
the measuring electrode 4 drops rapidly. Consequently, the output voltage E 0 increases rapidly. Therefore, 

35 the dropping of the liquid to the measuring electrode 4 can be detected by always monitoring the output 
voltage Eo of the current/voltage converter 53. 

Thus, the CPU 50 detects the change in the output voltage Eo of the current/voltage converter 53 based 
on a signal supplied thereto from the A/D converter 54, thus starting a measuring timer automatically. 

In adjusting the blood sugar value-measuring apparatus 1, an adjusting electrode is used. The adjusting 

40 electrode has a configuration similar to that of the measuring electrode 4 and a constant resistance value 
much smaller than that (infinite quantity) of an unused electrode. That is, when the voltage of the adjusting 
electrode is measured, the adjusting electrode indicates a stable and constant voltage from the beginning of 
measurement. Thus, the CPU 50 can discriminate several kinds of adjusting electrodes from each other 
based on different voltages. 

45 The adjusting electrode includes an adjusting mode switch-over one, an electrode for correcting error 
between the apparatuses, calibrating, testing one, and unit-switching one, etc. If the adjusting electrode is 
decided as the calibrating electrode, the CPU 50 automatically discriminates and selects a proper working 
curve corresponding to the calibrating electrode from a plurality of working curves stored in the blood sugar 
value-measuring apparatus, according to the resistance value (voltage) thereof. 

50 When the adjusting electrode is decided as the testing electrode, the voltage thereof is converted into a 
density, and the density is displayed on the LCD 2. The CPU 50 decides whether or not the blood sugar 
value-measuring apparatus is abnormal based on the density. 

When the adjusting electrode is decided as the unit-switching electrode, the voltage thereof is 
automatically altered/converted into each density unit (for example, mg/dl, mmol/L) so as to display the 

55 density unit on the LCD 2. Table 1 shows relations between the resistance value and the working curve for 
each calibrating electrode. 



6 



EP 0 651 250 A2 



Table 1 



5 



calibrating 
electrode No. 


resistance value (Kn) 


working curve No. 


0 


27 


F- 0 


1 


30 


F- 1 


2 


33 


F-2 


3 


36 


F-3 


4 


39 


F-4 


5 


43 


F-5 


6 


47 


F-6 


7 


51 


F-7 


8 


56 


F-8 


9 


62 


F-9 



It is possible to increase the number of terminals of the connector 3 so as to insert the calibrating 
electrode or the testing electrode into the terminals other than the terminal into which the electrode is 
inserted. 

25 There is a possibility that a method of discriminating the calibrating electrode or the testing electrode 
from other kinds of electrodes based on only the resistance value thereof leads to a decision that an 
electrode used which has been erroneously inserted into the connector 3 is the calibrating electrode or the 
testing electrode. In order to prevent such an erroneous decision, the following method is adopted in the 
portable blood sugar value-measuring apparatus 1 . 

30 A voltage E 0 i of an electrode inserted into the connector 3 is measured when the power supply is 
turned on, and a voltage E02 thereof is measured again at an interval of several seconds in relation to the 
point when the power supply is turned on. The rate of change (AE) in the two voltages is calculated. If the 
rate of change is greater than a predetermined level, it is decided that the electrode is the used one, and 
the result is displayed on the LCD 2. If the rate of change in the voltages is smaller than the predetermined 

35 level, it is decided that the electrode is the calibrating one or the testing one. 

[Equation 2] AE = :(Eoi - E02) + E01 ! 

If an unused electrode behaves similarly to an electrode used because the former absorbs moisture at 

40 a high humidity, liquid junction detecting terminals 9a and 9b are disposed alongside the electrode as 
shown in Fig. 11. Supposing that the liquid junction detecting terminals 9a and 9b are provided, when the 
resistance value therebetween is infinite, it is decided by the CPU 50 that there is no liquid junctions and 
that the electrode inserted into the connector 3 is unused, whereas if the resistance value therebetween is 
low, it is decided that the electrode has been already used. 

45 Fig. 12 is a detailed exploded perspective view showing another embodiment of an electrode. Fig. 13 is 
a perspective view showing the outlook of the electrode. 

There are provided on a substrate 31 a counter electrode 34, a measuring pole 35, leads 33, 32 
connected with the counter electrode 34 and the measuring pole 35, respectively, and an insulating layer 
36. Although not shown in Fig. 12, a reaction layer containing enzyme and mediator formed on the 

50 substrate 31 covers the counter electrode 34 and the measuring pole 35. A cover 39 is fixed to the upper 
surface of the substrate 31 via a spacer 37. To-be-measured liquid is introduced from a supply hole 38 to 
the counter electrode 34 and the measuring pole 35 by means of capillary action. Reference numeral 40 
denotes an air introducing hole. An inverse insertion-preventing projection 41 projects from a side surface of 
the electrode 45. When the electrode 45 is inserted into the connector 3 normally, the projection 41 is 

55 inserted into the gap, whereas if the electrode 45 is inserted into the connector 3 upside down, the 
projection 41 prevents the electrode 45 from being inserted into the gap. 

The operation of the blood sugar value-measuring apparatus disclosed in the above-described Patent 
Publication can be carried out by the blood sugar value-measuring apparatus 1 . 



7 



EP 0 651 250 A2 



Furthermore, the blood sugar value-measuring apparatus 1 according to this embodiment has each 
function of storing a measured blood sugar value, measuring the blood sugar value of the control liquid, 
reading the data of the measured blood sugar value stored in the RAM 70, and erasing the data of the 
measured blood sugar values. The CPU 50 executes the following various controls which will be described 
5 below. 

An embodiment of the data managing method applied to the portable blood sugar value-measuring 
apparatus 1 having the above-described construction and performing the above-described operation is 
described below. 

First, an embodiment of the data managing method to be carried out by the portable blood sugar value- 

10 measuring apparatus 1 in performing a normal blood sugar value-measuring function is described below 
with reference to Figs. 1 , 2, and 3. Figs. 1 and 2 are connected with each other via a reference character 
(P) and Figs. 2 and 3 are connected with each other via a reference character (T). 

When the measuring electrode 4 is inserted into the connector 3 of the apparatus 1 at step S1, the 
detecting circuit 52 outputs a mounting detection signal to the CPU 50. Upon receipt of the signal, the CPU 

is 50 outputs a signal to the buzzer 59. Then, the buzzer 59 generates an alarm indicating that the measuring 
electrode 4 has been inserted into the connector 3. At step S2, all segments of the LCD 2 are turned on for 
two seconds under the control of the CPU 50. The connector 3 and the detecting circuit 52 correspond to 
the electrode detecting means defined in the claim of the present invention. 

At step S3, the battery checking device 58 detects the voltage of the power battery 57 incorporated in 

20 the blood sugar value-measuring apparatus 1. At step S4, under the control of the CPU 50, electric current 
is applied to the electrode 45 inserted into the connector 3 via the reaction voltage setting circuit 63 and the 
current/voltage converter 53. In this manner, the CPU 50 detects the resistance value of the electrode 45. 
The CPU 50 decides whether the electrode 45 is the testing one, the calibrating one or the measuring one 
by detecting the resistance value of the electrode 45 through the current/voltage converter 53 and the A/D 

25 converter 54. The current/voltage converter 53 and the A/D converter 54 correspond to the signal output 
means defined in the claim of the present invention. The testing electrode means an electrode having a 
predetermined resistance value so that a predetermined blood sugar value is displayed on the LCD 2. 

If it is decided at step S4 that the electrode 45 inserted into the connector 3 is the testing electrode, the 
program goes to a process, shown in Fig. 4 via a reference character (Q), which will be described later, 

30 whereas if it is decided at step S4 that the electrode 45 inserted into the connector 3 is the calibrating one, 
the program goes to a process, shown in Fig. 5, via a reference character (R) which will be described later. 

Because the measuring electrode 4 has been inserted into the connector 3, the CPU 50 decides that 
the electrode 45 is the electrode for measuring a blood sugar value, thus starting the execution of the blood 
sugar value-measuring function. The preparatory process of functions to be executed terminates at steps S1 

35 through S4. 

The operations to be executed at steps S1 through S4 correspond to the preparatory process defined in 
the claim of the present invention. A preparatory portion 50a of the CPU 50 shown in Fig. 9 executes the 
preparatory process. 

The portable blood sugar value-measuring apparatus 1 can store 10 latest measured blood sugar 
40 values. After the preparatory process terminates at steps S1 through S4, a measurement number of the first 
time measurement through the 10th time measurement indicating a current measurement and a working 
curve number (F-0 through F-10, as shown in Table 1) indicating the kind of the working curve are 
alternately displayed on the LCD 2 at intervals of one second at step S5. 

At step S6, the CPU 50 starts clocking one minute from the point when the preparatory process has 
45 terminated, namely, from the point when the alternate display of the measurement number and the working 
curve number has been started. It is to be noted that the clocking time period is not limited to one minute. 

The operations to be executed at steps S5 and S6 correspond to the first clocking process defined in 
the claim of the present invention. A first clocking portion 50b of the CPU 50 shown in Fig. 9 executes the 
first clocking process. 

so At step S7, the CPU 50 decides whether or not the resistance value of the measuring electrode 4 has 
changed rapidly due to the dropping of blood to the measuring electrode 4 during the period of time from 
the point when clocking operation has started until the termination of one minute. If the dropping of the 
blood has been detected at step S7, the program goes to step $11 which will be described later to measure 
the blood sugar value, whereas if the dropping of the blood has not been detected at step S7, the program 

55 returns to step S5. 

The operation to be executed at step $7 corresponds to the deciding process defined in the claim of 
the present invention. A deciding portion 50c of the CPU 50 shown in Fig. 9 executes the deciding process. 



8 



EP 0 651 250 A2 



At steps S6 and S7, it is possible to drop control liquid to the measuring electrode 4 instead of blood. 
The control liquid-measuring function is described below. 

The control liquid means liquid having a density adjusted to a known, or predetermined density of 
glucose. The control liquid-measuring function means a function of checking whether or not a blood sugar 

5 value-measuring/calculating circuit or the like of the portable blood sugar value-measuring apparatus 1 is 
abnormal condition and whether or not measuring electrodes having the same lot number as that of the 
measuring electrode 4 used to the control liquid -measuring function of the control liquid has defect, based 
on the operator's decision that a blood sugar value, corresponding to the density of glucose of the control 
liquid, indicated on the LCD 2 by dropping the control liquid to the measuring electrode 4 is included within 

w a predesignated blood sugar value. The blood sugar value measured by using the control liquid is stored in 
the RAM 70. In order to distinguish the blood sugar value, measured by using blood, to be stored in the 
RAM 70 and the blood sugar value, measured by using the control liquid, to be stored in the RAM 70 from 
each other, the following operation is performed in dropping the control liquid to the measuring electrode 4. 
At steps S6 and S7, the measuring electrode 4 is pulled out from the portable blood sugar value- 

?5 measuring apparatus 1. As a result, the alternate display of the measurement number and the working 
curve number terminates, and either the former or the latter remains displayed on the LCD 2 for three 
seconds. When the measuring electrode 4 is inserted into the connector 3 again during the three seconds, 
as a display indicating that the control liquid is measured next, for example, the display of a character "C" 
and the display of characters "F-0" indicating the display of the working curve number are made alternately 

20 on the LCD 2. In this manner, the control liquid-measuring function is performed. When the measuring 
electrode 4 is not inserted into the connector 3 within the three seconds, the power supply is turned off. 
When the control liquid is dropped to the measuring electrode 4, a measuring operation is performed 
similarly to the method of dropping blood to the measuring electrode 4, and the RAM 70 stores the 
character, for example, "C" indicating the measured value of the control liquid and the blood sugar value 

25 measured by using the control liquid. The method of measuring a blood sugar value by dropping blood to 
the measuring electrode 4 is described later. 

If it is decided at step S6 that blood has not been dropped the measuring electrode 4 within one 
minute, the program goes to step S8. At step S8, the CPU 50 reads the data of measured blood sugar 
values stored in the RAM 70, thus outputting memory numbers and the data of the measured blood sugar 

30 values corresponding to the respective memory numbers to the LCD 2 in this order. The LCD 2 displays 
the memory numbers and the data of the measured blood sugar values corresponding to the respective 
memory numbers in this order. 

The operation to be executed at step S8 corresponds to the read-out process defined in the claim of 
the present invention. A read-out portion 50d of the CPU 50 shown in Fig. 9 executes the read-out process. 

35 The display of the memory numbers and that of the data of the measured blood sugar values 
corresponding to the respective memory numbers are described below with reference to Fig. 6 and Tables 
2 - 4. First, the display of a character, for example, "A" indicating the average value of all measured blood 
sugar values stored in the RAM 70 is displayed on the LCD 2 for one second and then, the display of the 
character "A" is terminated and then, the average value is displayed for two seconds. Then, as shown in 

40 Table 2, a latest measured blood sugar value through an oldest one are sequentially displayed. That is, 
when the two seconds have elapsed, the display of the average value is terminated and then, "3" which is 
the memory number storing the latest measured blood sugar value is displayed for one second. When one 
second has elapsed, the display of the character "3" is terminated and then, a measured blood sugar value 
corresponding to the memory number "3" is displayed for two seconds. At the termination of two seconds 

45 during which the measured blood sugar value corresponding to the memory number "3" is displayed, the 
display of the measured blood sugar value corresponding to the memory number "3" is terminated. Then, a 
memory number n 2" is displayed for one second. When one second has elapsed, the display of the 
character "2" is terminated and then, a measured blood sugar value corresponding to the memory number 
"2" is displayed for two seconds. Similarly, the displays of measured blood sugar values corresponding to 

50 the memory numbers "5" and "4 W are sequentially executed. 

The read-out method of the data of the measured blood sugar values stored in the RAM 70 is not 
limited to the above-described one, but it is possible to display the measured blood sugar values in the 
order from the oldest one to the latest one and alter the above-described display time period of each data 
to a different one. 

55 Table 4 shows an example the read-out of the data of measured blood sugar values from the RAM 70 
when the control liquid-measuring function is executed and a blood sugar value measured by using the 
control liquid is stored in the RAM 70. A character "C" in Table 4 shows a portion in which the control 
liquid-measuring function has been executed. When the control liquid-measuring function is executed and 



9 



EP 0 651 250 A2 



the blood sugar value measured by using the control liquid is stored in the RAM 70, the above-described 
average value is calculated based on only the data of the blood sugar values measured by using blood. 
That is, the data of the blood sugar values measured by using the control liquid is not used in finding the 
average value. 

Table 2 



memory No. 


4 5 6 


7 8 


9 


10 1 


2 3 


data 


oldest 




--> 




latest 


read-out order 


A 3 2 


1 10 


9 


8 7 


6 5 4 


Table 3 


memory No . 


4 5 6 


7 8 


9 


10 1 


2 3 


data 


oldest 




--> 




latest 


read- out order 


A 4 5 


6 7 


8 


9 10 1 


2 3 


Table 4 


memory No. 


4 5 6 


C 7 


8 


9 10 


1 2 


data 


oldest 




---> 




latest 


read-out order 


A 2 1 


10 9 


8 


7 C 


6 5 4 



At step S9, it is decided whether the display of all the measured blood sugar values stored in the RAM 
30 70 has terminated. If the display of all the measured blood sugar values stored in the RAM 70 has 
terminated at step S9, the power supply of the blood sugar value-measuring apparatus 1 is turned off. 

If it is detected at step S10 that the blood or the control liquid has been dropped to the measuring 
electrode 4 before the displays of all the measured blood sugar values terminate at step S9, the program 
goes to step S1 1 . 

35 As described above, in the embodiment, the blood sugar value-measuring apparatus 1 can display the 

blood sugar values stored in the RAM without providing with an operation butter. 

The operation to be executed at step S10 corresponds to the dropping deciding process defined in the 

claim of the present invention. An dropping deciding portion 50k of the CPU 50 shown in Fig. 9 executes 

the dropping deciding process. 
40 Furthermore, if the electrode is installed on or removed from the portable blood sugar value-measuring 

apparatus 1 between the operation to be executed at step S8 and the operation to be executed at step S9, 

namely, while the data of the measured blood sugar values read out from the RAM 70 is being outputted to 

the LCD 2, the data of all the measured blood sugar values stored in the RAM 70 is erased. 

That is, it is decided at step S50 whether the electrode is removed from the portable blood sugar value- 
rs measuring apparatus 1. If the electrode is not removed therefrom at step S50, the program goes to step S9, 

whereas if the electrode is removed therefrom at step S50, the program goes to step S51. 

It is decided at step S51 whether the electrode has been mounted again on the portable blood sugar 

value-measuring apparatus 1 within three seconds after the electrode is removed therefrom. If no at step 

S51, the power supply is turned off. At this time, the data of the measured blood sugar values stored in the 
so RAM 70 is not erased. If yes at step S5t, the program goes to step S52 at which the data of all the 

measured blood sugar values stored in the RAM 70 is erased. Then, the power supply is turned off. 

The operations to be executed at steps S50 through S52 correspond to the data erasing process 

defined in the claim of the present invention. A data erasing portion 50] shown in Fig. 9 executes the data 

erasing process. 

55 The period of time between the point when the electrode is removed from the connector 3 and the point 
when the electrode is mounted thereon again is not limited to three seconds. It is also possible to erase a 
part of all the data stored in the RAM 70. 



10 



EP 0 651 250 A2 



Further, the kind of the electrode to be mounted on or removed from the portable blood sugar value- 
measuring apparatus 1 is not limited to a specific kind of electrode. 

As described above, in the embodiment, the blood sugar value-measuring apparatus 1 can erase the 
data of the blood sugar values stored in the RAM 70 without providing with the operation button. 
5 The operation of starting the measurement of a blood sugar value is described below, supposing that 
blood or the control liquid has been dropped to the measuring electrode 4 within one minute at steps S6 
and S7 or the dropping of the blood or the control liquid has been detected a step S1 0. 

In this case, the CPU 50 measures atmospheric temperature T1 at step S11 by using a thermistor 
mounted on the portable blood sugar value-measuring apparatus 1 immediately before the blood sugar 
70 value is measured. 

At steps S12 and S13, the CPU 50 waits for a predetermined reaction time period from the point when 
the dropping of the blood to the measuring electrode 4 has been detected at step S11 until the point when 
the reaction of the blood dropped to the measuring electrode 4 and a reagent layer formed in the 
measuring electrode 4 takes place. At step S14, when the reaction time period has terminated, the CPU 50 

/5 measures a temperature T2 by using the thermistor immediately after the blood sugar value is measured. 

At step S15, the CPU 50 subtracts the temperature T1 measured at step S11 from the temperature T2 
measured at step S14, thus deciding whether the absolute value of a value obtained by the subtraction is 
greater than a predetermined value K. If the absolute value is greater than the value K, the LCD 2 executes 
an error display under the control of the CPU 50. The temperature in the reaction of the blood and the 

20 reagent layer of the measuring electrode 4 affects greatly on a measured blood sugar value. Thus, when 
the temperature difference between the temperature before the measurement and that after the measure- 
ment is higher than the predetermined value K, the measured blood sugar value is not reliable, if the 
absolute value is equal or less to the value K at step S15, the program goes to step S17 at which the CPU 
50 issues an instruction to the reaction voltage setting circuit 63 to apply a predetermined voltage to the 

25 measuring electrode 4, thus measuring the value of oxidation current. Based on the measured value of the 
oxidation current, the CPU 50 calculates a blood sugar value, thus outputting a signal to the LCD 2 at step 
S18 so that the blood sugar value is displayed thereon. In displaying the blood sugar value, the CPU 50 
also outputs a signal to the buzzer 59 to inform a user of the completion of the measurement. 

The operations to be executed at steps 12, 13, 17, and 18 are similar to those to be executed in the 

30 blood sugar value-measuring apparatus disclosed in the Patent Publication. 

The operations to be executed at steps S11 through S17 correspond to the blood sugar value- 
measuring process defined in the claim of the present invention. A blood sugar value-measuring portion 50e 
of the CPU 50 shown in Fig. 9 executes the blood sugar value-measuring process. 

At step S19, the CPU 50 decides whether three minutes have elapsed from the start point of the display 

35 of the measured blood sugar value executed at step S18, namely, from the point when the process of 
measuring the blood sugar value has been completed. The operations to be executed at steps S18 and S19 
correspond to the second clocking process defined in the claim of the present invention. A second clocking 
portion 50f of the CPU 50 shown in Fig. 9 executes the second clocking process. 

It is decided at step S20 whether or not the user has pulled out the measuring electrode 4 from the 

40 connector 3 before the three minutes elapse. This decision is made based on whether the mounting 
detection signal has been supplied from the detecting circuit 52 to the CPU 50. If the measuring electrode 4 
is not pulled out therefrom at step S20, the program returns to step S18, thus executing operations between 
steps S18 and S20, whereas if the measuring electrode 4 is pulled out therefrom at step S20, the program 
goes to step S21. The decision as to whether the mounting detection signal has been supplied from the 

45 detecting circuit 52 to the CPU 50 is made based on the level, namely, a high level and a low level of the 
mounting detection signal. 

At step S21, the CPU 50 starts counting three seconds from the point when the CPU 50 has detected 
the removal of the measuring electrode 4 from the connector 3 at step S20, thus deciding whether or not 
the measuring electrode 4 has been inserted into the connector 3 again within the three seconds based on 

50 whether the mounting detection signal has been supplied from the detecting circuit 52 to the CPU 50. If the 
CPU 50 has detected the insertion of the measuring electrode 4 within three seconds at step S21 , the CPU 
50 outputs a signal to the RAM 70 not to store the data of the currently measured blood sugar value, 
namely, to execute the measurement result-erasing function, the power supply of the blood sugar value- 
measuring apparatus 1 is turned off under the control of the CPU 50. If the CPU 50 has not detected the 

55 insertion of the measuring electrode 4 within three seconds at step S21 , the program goes to step S22 at 
which the RAM 70 stores the data of the currently measured blood sugar value. Then, the power supply is 
turned off. 



11 



EP 0 651 250 A2 



If the measuring electrode 4 is not removal from the connector 3 at step S20, the program returns to 
step S18 to continue the operations at steps S18 through S20. When it is decided at step S19 that three 
minutes have elapsed, the program goes to step S22 at which the RAM 70 stores the data of the currently 
measured blood sugar value. 
5 The operations to be executed at steps S20 and S21 correspond to the writing permis- 
sion/nonpermission deciding process defined in the claim of the present invention. A writing permis- 
sion/nonpermission deciding portion 50g of the CPU 50 shown in Fig. 9 executes the writing permis- 
sion/nonpermission deciding process. The operation to be executed at step S22 corresponds to the writing 
process defined in the claim of the present invention. A writing portion 50h of the CPU 50 shown in Fig. 9 
w executes the writing process. 

Description is made on an embodiment of the data managing method in performing a measuring 
function by means of the testing electrode and the calibrating (switch-over of working curve) function with 
reference to Figs. 4 and 5, supposing that the testing electrode or the calibrating electrode has been 
inserted into the connector 3. 
15 The measuring function by means of the testing electrode means a function to check whether or not the 
portable blood sugar value-measuring apparatus 1 operates normally. The CPU 50 decides that the 
electrode inserted into the connector 3 is the testing electrode according to a predetermined resistance 
value of the testing electrode and converts the resistance value into a blood sugar value, thus outputting a 
signal to the LCD 2 so that the measured blood sugar value is displayed thereon. 
20 Referring to Fig. 4, the operation of the measuring function by means of the testing electrode is 
described below. When it is decided at step S4 that the electrode inserted into the connector 3 is the 
testing electrode, the program goes to step S30 at which the CPU 50 converts the resistance value of the 
testing electrode into a blood sugar value, thus outputting a signal to the LCD 2 so that the measured blood 
sugar value measured by means of the testing electrode is displayed thereon. 
25 It is decided at step S31 whether or not the testing electrode has been pulled out from the connector 3. 
The CPU 50 makes the decision based on whether or not the detecting circuit 52 has supplied the 
mounting detection signal to the CPU 50. If the testing electrode has been pulled out therefrom at step S31 , 
the power supply of the portable blood sugar value-measuring apparatus 1 is turned off under the control of 
the CPU 50. If the testing electrode has not been pulled out therefrom at step S31, the CPU 50 decides at 
30 step S32 whether or not 10 seconds have elapsed from the point when the electrode was inserted into the 
connector 3 at step SI. If 10 seconds have not elapsed and the testing electrode has not been pulled out 
from the connector 3, the program returns to step S30 to repeatedly perform the operations at steps S30 
through S32. When 10 seconds have elapsed at step S32 without the testing electrode being removed from 
the connector 3, the program goes to step S33 at which the CPU 50 reads out the data of the past 10 
35 measured blood sugar values stored in the RAM 70, thus outputting the data of the 10 measured blood 
sugar values sequentially to the LCD 2. The data of the 10 measured blood sugar values is displayed in the 
same procedure as that to be performed at step S8. 

It is probable that the CPU 50 performs the data erasing operation (step S50 through S52) as described 
above before the output of the data of ail the measured blood sugar values read out from the RAM 70 is 
40 completed. That is, it is decided at step S50 subsequent to step S33 whether or not the electrode has been 
removed from the portable blood sugar value-measuring apparatus 1. If the electrode has not been removed 
therefrom at step S50, the program goes to step S53, whereas if the electrode has been removed therefrom 
at step S50, the program goes to step S51 . 

It is decided at step S51 whether or not the electrode has been mounted again on the portable blood 
45 sugar value-measuring apparatus 1 within three seconds after the removal of the electrode therefrom. If the 
electrode has not been mounted again at step S51, the power supply is turned off under the control of the 
CPU 50. At this time, the data of the measured blood sugar values stored in the RAM 70 is not erased. If 
the electrode has been mounted again at step S51 , the program goes to step S52 at which the CPU 50 
erases the data of all the measured blood sugar values stored in the RAM 70. Then, the power supply is 
so turned off under the control of the CPU 50. 

It is decided at step S53 whether the output of the data of all the measured blood sugar values read out 
from the RAM 70 is completed. If the output is not completed at step S53. the program returns to step S33, 
whereas if the output is completed at step 53, the power supply is turned off. 

The calibrating (switch-over of working curve) function means a function to specify one working curve 
55 from among data of a plurality of working curve stored in the portable blood sugar value-measuring 
apparatus 1. The CPU 50 decides that an electrode inserted into the connector 3 is the calibrating electrode 
according to a predetermined resistance value of the electrode, thus specifying a working curve designated 
by the calibrating electrode. 



12 



EP 0 651 250 A2 



The operation of the calibrating function is described below with reference to Fig. 5. If it is decided at 
step S4 that an electrode inserted into the connector 3 is the calibrating electrode, the program goes to 
step S40 at which the working curve number is displayed on the LCD 2 under the control of the CPU 50, 
based on the resistance value of the calibrating electrode. 

5 It is decided at step S41 whether or not the calibrating electrode has been pulled out from the 
connector 3. The CPU 50 makes the decision based on whether or not the detecting circuit 52 has 
outputted the mounting detection signal to the CPU 50. If the calibrating electrode has been pulled out from 
the connection 3 at step S41, the power supply of the portable blood sugar value-measuring apparatus 1 is 
turned off under the control of the CPU 50. If the calibrating electrode has not been pulled out from the 

70 connection 3 at step S41, the CPU 50 decides whether or not 10 seconds have elapsed from the point 
when the electrode was inserted into the connector 3 at step SI. If 10 seconds have not elapsed and the 
calibrating electrode has not been pulled out from the connector 3, the program returns to step S40 to 
repeatedly perform the operations at steps S40 through S42. When 10 seconds have elapsed at step S42 
without the calibrating electrode being removed from the connector 3, the program goes to step S43 at 

;5 which the CPU 50 reads out the data of the past 10 measured blood sugar values stored in the RAM 70, 
thus outputting the data of the read-out measured blood sugar values sequentially to the LCD 2. The data of 
the read-out measured blood sugar values is displayed in the same procedure as that to be performed at 
step S8. 

It is probable that the CPU 50 executes the data erasing operation (step S50 through S52) as described 
20 above before the output of the data of all the measured blood sugar values read out from the RAM 70 is 
completed. That is, it is decided at step S50 subsequent to step S43 whether or not the electrode has been 
removed from the portable blood sugar value-measuring apparatus 1. If the electrode has not been removed 
therefrom at step S50, the program goes to step S53, whereas if the electrode has been removed therefrom 
at step S50, the program goes to step S51 . 
25 It is decided at step S51 whether or not the electrode has been mounted again on the portable blood 
sugar value-measuring apparatus 1 within three seconds after the removal of the electrode therefrom. If the 
electrode has not been mounted again at step S51, the power supply is turned off under the control of the 
CPU 50. At this time, the data of the measured blood sugar values stored in the RAM 70 is not erased. If 
the electrode has been mounted again at step S51, the program goes to step S52 at which the CPU 50 
30 erases the data of all the measured blood sugar values stored in the RAM 70. Then, the power supply is 
turned off. 

it is decided at step S53 whether the output of the data of all the measured blood sugar values read out 

from the RAM 70 is completed. If the output is not completed at step S53, the program returns to step S43, 

whereas if the output is completed at step 53, the power supply is turned off. 
35 As described above, the data stored in the RAM 70 can be displayed as short as 10 seconds after the 

testing electrode or the calibrating electrode is inserted into the connector 3, whereas the data stored in the 

RAM 70 is displayed as long as one minute after the measuring electrode 4 is inserted into the connector 3. 
The operations to be executed at steps S30 and S40 correspond to the predetermined value-display 

process defined in the claim of the present invention. A predetermined value-display portion 50i of the CPU 
40 50 shown in Fig. 9 executes the predetermined value display process. The operations to be executed at 

steps S31 through S33 and S41 correspond to the first clocking process, the deciding process, and the 

read-out process, respectively. 

As described above, according to the data managing method of the present invention comprises a data 

managing method, to be carried out in a portable blood sugar value-measuring apparatus having no 
45 operation button, of selectively and removably mounting one of electrodes on the apparatus to execute a 

function in correspondence with a resistance value of the selected electrode, comprising: 

a preparatory process of mounting the electrode on the portable blood sugar value-measuring 

apparatus to set the apparatus to an operation start state and select the function to be executed in 

correspondence with the mounted electrode; 
so a first clocking process of clocking a first predetermined period of time after the execution of the 

preparatory process terminates; 

a deciding process for deciding whether the first clocking process has been switched over to a blood 

sugar value-measuring process for measuring a blood sugar value of to-be-measured liquid which has 

dropped to the mounted electrode while clocking the first predetermined period of time is being executed in 
55 the first clocking process, a measured blood sugar value in the blood sugar value-measuring process is 

stored in a storing means when it is decided that the measured blood sugar value is to be stored in the 

storing means; and 

a read-out process for reading out data stored in the storing means from a termination point of the first 



13 



EP 0 651 250 A2 



predetermined period of time and outputting the data read out from the storing means when the first 
predetermined period of time has terminated without the switch-over from the first clocking process to the 
blood sugar value-measuring process being decided in the deciding process. 

By the above construction, it is decided whether or not the first clocking process has been switched 

5 over to a blood sugar value-measuring process for measuring the blood sugar value of to-be-measured 
liquid while the operation of clocking the first predetermined period of time is being executed in the first 
clocking process. If it is decided that the first clocking process has not been switched over to the a blood 
sugar value-measuring process for measuring the blood sugar value of to-be-measured liquid, the read-out 
of the data of measured blood sugar values stored in the storing means is started from the termination point 

10 of the first predetermined period of time. Thus, in the portable blood sugar value-measuring apparatus 
having no operation buttons, the data of the measured blood sugar values can be smoothly read out from 
the storing means. 

In the read-out process, a data erasing process may be provided. By this construction, decisions are 
made as whether or not the mounted electrode has been removed from the portable blood sugar value- 
rs measuring apparatus while the data of the measured blood sugar values are being read out and then 
whether or not the electrode has been mounted thereon. The data of all of the measured blood sugar values 
stored in the storing means is erased in a predetermined condition. Thus, in the portable blood sugar value- 
measuring apparatus having no operation buttons, the data of the measured blood sugar values stored in 
the storing means can be smoothly erased. 
20 In the read-out process, a dropping deciding process may be provided. By this construction, whether or 
not to-be-measured liquid has been dropped on the electrode is decided while the data of the measured 
blood sugar values is being read out from the storing means. Accordingly, in the portable blood sugar 
value-measuring apparatus having no operation buttons, the display of the measured blood sugar values 
can be switched over smoothly to the blood sugar value-measuring operation or can be continued. 
25 When a blood sugar value-measuring function is selected in the preparatory process, a blood sugar 
value-measuring process and a writing process may be provided. By this construction, the data of the 
measured blood sugar values is written to the storing means. Accordingly, in the portable blood sugar 
value-measuring apparatus having no operation buttons, the data of the measured blood sugar values can 
be smoothly written to the storing means. 
30 When a resistance value-measuring function is selected in the preparatory process, a predetermined 
value display process may be provided. By this construction, a predetermined value is displayed when the 
resistance value-measuring function is selected. Accordingly, in the portable blood sugar value-measuring 
apparatus having no operation buttons, the predetermined value can be smoothly displayed when the 
resistance value-measuring function is selected. 
35 A second clocking process and a writing permission/nonpermission deciding process may be provided. 
By this construction, the writing of the data of a currently measured blood sugar value to the storing means 
is suspended. Accordingly, in the portable blood sugar value-measuring apparatus having no operation 
buttons, the data of the measured blood sugar values can be smoothly managed. 

When that the blood sugar value-measuring function is selected in the preparatory process, a liquid 
40 kind-classifying data-output process may be provided. By the construction the liquid kind-classifying data is 
outputted to the storing means when it is decided that the mounted electrode has been removed from the 
portable blood sugar value-measuring apparatus and then mounted thereon so as to allow the operation of 
measuring the blood sugar value of the liquid to be executed. Thus, the data of the measured blood sugar 
values to be stored in the storing means can be classified, and hence, in the portable blood sugar value- 
rs measuring apparatus having no operation buttons, the data of the measured blood sugar values can be 
smoothly managed. 

According to the portable blood sugar value-measuring apparatus of the present invention comprises a 
portable blood sugar value-measuring apparatus, having no operation button, for selecting a function to be 
executed based on one of electrodes each of which has resistance value executing a function, the 

so apparatus having an electrode detection means for detecting whether or not one of the electrodes 
removable therefrom has been mounted thereon, thus outputting a mounting detection signal; and a signal 
output means, connected with an output side of the electrode detection means, for outputting a function 
selection signal based on a resistance value of the electrode mounted on the portable blood sugar value- 
measuring apparatus, the apparatus comprising: 

55 a storing means for storing data of measured blood sugar values obtained by executing a blood sugar 
value-measuring function selected based on the resistance value of the mounted electrode; 

a preparatory means, connected with the output side of the electrode detection means and an output 
side of the signal output means, for setting the portable blood sugar value-measuring apparatus to an 



14 



EP 0 651 250 A2 



operation start state when the electrode detection means detects that the electrode has been mounted on 
the portable blood sugar value-measuring apparatus and selecting the function to be executed based on the 
function selection signal; 

a first clocking means connected with an output side of the preparatory means, for clocking a first 

s predetermined period of time from a point when the function is selected by the preparatory means; 

a deciding means, connected with an output side of the first clocking means, the output side of the 
electrode detection means, and the output side of the signal output means, for deciding whether or not the 
mounting detection signal and the function selection signal have been supplied while clocking the first 
predetermined period of time is being executed; and 

10 a read-out means, connected with the output side of the deciding means and an output side of the 
storing means, for reading out the data of the measured blood, sugar values stored in the storing means 
from a point when the first predetermined period of time has terminated and outputting the data of the 
measured blood sugar values when the first predetermined period of time has terminated without the 
deciding means deciding whether or not the function selection signal has been supplied. 

75 By this construction, it is decided whether or not the function selection signal has been supplied while 
the operation of clocking the first predetermined period of time is being executed in the first clocking 
process. If it is decided that the function selection signal has not been supplied, the read-out of the data of 
the measured blood sugar values stored in the storing means is started from the termination point of the i 
first predetermined period of time. Thus, in the portable blood sugar value-measuring apparatus having no 

20 operation buttons, the data of the measured blood sugar values can be smoothly read out from the storing 
means. 

A data erasing means may be provided. By this construction, the data erasing means erases the data of 
the measured blood sugar values stored in the storing means when the mounted electrode has been 
removed from the portable blood sugar value-measuring apparatus before all the data of the measured 

25 blood sugar values read out from the storing means is outputted from the read-out means and then the 
electrode has been mounted thereon. 

Namely, decisions are made as whether or not the mounted electrode has been removed from the 
portable blood sugar value-measuring apparatus before the data of the measured blood sugar values are 
being read out from the storing means and then whether or not the electrode has been mounted thereon 

30 before a predetermined period of time is terminated. The data of all of the measured blood sugar values 
stored in the storing means is erased in a predetermined condition. Thus, in the portable blood sugar value- 
measuring apparatus having no operation buttons, the data of the measured blood sugar values stored in 
the storing means can be smoothly erased. 

A blood sugar value-measuring means and a writing means may be provided. By this construction, in 

35 executing the blood sugar value-measuring function, when the deciding means has decided that the 
function selection signal has been supplied, the blood sugar value-measuring means measures the blood 
sugar values of to-be-measured liquid and the writing means writes the data of the measured blood sugar 
value to the storing means. 

The data of the measured blood sugar values is written to the storing means. Accordingly, in the 

40 portable blood sugar value-measuring apparatus having no operation button, the data of the measured blood 
sugar values can be smoothly written to the storing means. 

An dropping means may be provided. By this construction, the dropping deciding means decides 
whether or not the function selection signal has been supplied while the read-out means is outputting data 
of the blood sugar values read out from the ding to the blood sugar value-measuring apparatus as define 

45 storing means. The dropping deciding means allows the measurement of a blood sugar value to be 
executed when it is decided that the function selecting signal has been supplied, whereas it allows the 
output of the data of the measured blood sugar values to be continued when rt is decided that the function 
selection signal has not been supplied. 

Whether or not to-be-measured liquid has been dropped to the electrode is decided while the data of 

so the measured blood sugar values read out from the storing means is being outputted. Accordingly, in the 
portable blood sugar value-measuring apparatus having no operation buttons, the display operation can be 
switched over smoothly to the blood sugar value-measuring operation or can be continued in the outputting 
the data. 

A second clocking means and a writing permission/nonpermission deciding means may be provided. 
55 By this construction, the writing permission/nonpermission deciding means decides whether or not the data 
of the measured blood sugar value should be written to the storing means based on whether or not the 
mounted blood sugar value-measuring electrode has been removed from the portable blood sugar value- 
measuring apparatus before the second predetermined period of time terminates and then whether or not it 



15 



EP 0 651 250 A2 



has been mounted thereon again before a predetermined period of time terminates. The writing permis- 
sion/nonpermission deciding means suspends the writing of the data of a currently measured blood sugar 
value to the storing means. 

Accordingly, in the portable blood sugar value-measuring apparatus having no operation buttons, the 
5 data of the measured blood sugar values can be smoothly managed. 

A display means and a predetermined value-display means may be provided. By this construction, the 
predetermined value-display means causes the display means to display a predetermined vale based on 
the resistance value of an electrode mounted on the portable blood sugar value-measuring apparatus. 

The predetermined value is written to the storing means when a resistance value-measuring function is 
70 selected. Accordingly, in the portable blood sugar value-measuring apparatus having no operation button, 
the predetermined value can be smoothly written to the storing means when the resistance value-measuring 
function is selected. 

When that the blood sugar value-measuring function is selected, the deciding means outputs the liquid 
kind-classifying data to the writing means when it is decided that the mounted blood sugar value-measuring 
75 electrode has been removed from the portable blood sugar value-measuring apparatus and then mounted 
thereon again. Thus, the storing means stores the blood sugar value to which the liquid kind-classifying data 
is attached. That is, the deciding means has a function of classifying the data of the measured blood sugar 
value. 

The liquid kind-classifying data is outputted to the storing means when it is decided that the blood 
20 sugar value-measuring electrode has been removed from the portable blood sugar value-measuring 
apparatus and then mounted thereon again. Thus, the data of the measured blood sugar values to be stored 
in the storing means can be classified in the blood sugar value-measuring operation to be executed 
thereafter. Hence, in the blood sugar value-measuring apparatus having no operation buttons, the data of 
the measured blood sugar values can be smoothly managed. 
25 As described above, in this construction of the portable blood sugar value-measuring apparatus having 
no operation buttons thereon, the data erasing means, the blood sugar value-measuring means, the writing 
means, the dropping deciding means, the second clocking means, the writing permission/nonpermission 
deciding means, and the predetermined value-display means act smoothly to read out the data of the 
measured blood sugar values from the storing means and to suspend the writing of data of the blood sugar 
30 values or the like. 

It is to be noted that the storing means corresponds to the RAM in the embodiment; the electrode 
detecting means corresponds to the connector and the detecting circuit in the embodiment; the signal 
output means corresponds to the current/voltage converter and the A/D converter; the preparatory means, 
the first clocking means, the deciding means, the read-out means, the blood sugar value-measuring means, 

35 the writing means, the second clocking means, the writing permission/nonpermission deciding means, the 
predetermined value-display means, the dropping deciding means, and the data erasing means correspond 
to the central processing unit in the embodiment. 

The liquid kind-classifying data output from the deciding means to the writing means data correspond- 
ing to "C" written to the storing means when control liquid is measured in the embodiment. 

40 Although the present invention has been fully described in connection with the preferred embodiments 
thereof with reference to the accompanying drawings, it is to be noted that various changes and 
modifications are apparent to those skilled in the art. Such changes and modifications are to be understood 
as included within the scope of the present invention as defined by the appended claims unless they depart 
therefrom. 

45 

Claims 

1. A data managing method, to be carried out in a portable blood sugar value-measuring apparatus having 
no operation button, of selectively and removably mounting one of electrodes on the apparatus to 
50 execute a function in correspondence with a resistance value of the selected electrode, comprising: 

a preparatory process (S1-S4) of mounting the electrode on the portable blood sugar value- 
measuring apparatus to set the apparatus to an operation start state and select the function to be 
executed in correspondence with the mounted electrode; 

a first clocking process (S5, S6) of clocking a first predetermined period of time after the execution 
55 of the preparatory process terminates; 

a deciding process (S7) for deciding whether the first clocking process has been switched over to a 
blood sugar value-measuring process (S11-S17) for measuring a blood sugar value of to-be-measured 
liquid which has dropped to the mounted electrode while clocking the first predetermined period of time 



16 



EP 0 651 250 A2 



is being executed in the first clocking process, a measured blood sugar value in the blood sugar value- 
measuring process is stored in a storing means when it is decided that the measured blood sugar value 
is to be stored in the storing means; and 

a read-out process (S8) for reading out data stored in the storing means from a termination point of 
5 the first predetermined period of time and outputting the data read out from the storing means when 
the first predetermined period of time has terminated without the switch-over from the first clocking 
process to the blood sugar value-measuring process being decided in the deciding process. 

2. The data managing method as claimed in claim 1 , wherein the read-out process includes a data erasing 
io process (S50-S52) for deciding whether or not the mounted electrode has been removed from the 

portable blood sugar value-measuring apparatus before the data of all of the measured blood sugar 
values read out from the storing means is outputted and then whether or not the electrode has been 
mounted thereon before a predetermined period of time terminates; and erasing the data of all of the 
measured blood sugar values stored in the storing means when it is decided that the mounted 
75 electrode, has been removed from the portable blood sugar value-measuring apparatus before the data 
of all of the measured blood sugar values read out from the storing means is outputted and then the 
electrode has been mounted thereon before the predetermined period of time terminates. 

3. The data managing method as claimed in claim 1 or 2, wherein the read-out process includes a 
20 dropping deciding process (S10) for deciding whether or not the to-be-measured liquid has been 

dropped to the electrode before the data of all of the measured blood sugar values read out from the 
storing means is outputted; allowing the process of measuring the blood sugar value of the liquid to be 
executed when it is decided that the liquid has been dropped to the mounted electrode before the data 
of all of the measured blood sugar values read out from the storing means is outputted; and continuing 
25 the output of the data of all of the measured blood sugar values when it is decided that the liquid has 
not been dropped to the mounted electrode before the data of all of the measured blood sugar values 
read out from the storing means is outputted. 

4. The data managing method as claimed in claim 1, further comprising a writing process (S22) for writing 
30 the data of the blood sugar value measured in the blood sugar value-measuring process to the storing 

means after the execution of the blood sugar value-measuring process terminates, wherein when the 
selected function in the preparating process is to measure a blood sugar value and when it is decided 
in the deciding process due to the dropping of the liquid to the mounted electrode that the first clocking 
process has been switched over to the blood sugar value-measuring process, the writing process is 
35 executed. 

5. The data managing method as claimed in claim 1 or 2, further comprising a predetermined value 
display process, provided subsequently to the preparatory process, for displaying a predetermined 
value based on the electrode mounted on the portable blood sugar value-measuring apparatus, 

40 wherein, when a resistance value-measuring function is selected in the preparatory process, the display 
process is executed. 

6. The data managing method as claimed in any one of claims 1 - 3, and 5, wherein when the storing 
means stores the data of a plurality of measured blood sugar values, the read-out process comprises 

45 the steps of reading out an average value of the measured blood sugar values and subsequently, the 
data of each of the measured blood sugar values sequentially at predetermined intervals. 

7. The data managing method as claimed in claim 4 or 6, further comprising: 

a second clocking process (S18.19), provided between the blood sugar value-measuring process 
so and the writing process, for clocking a second predetermined period of time from a point when the 
execution of the measuring blood sugar value-measuring process terminates; and 

a writing permission/nonpermission deciding process (S20.21), provided between the blood sugar 
value-measuring process and the writing process, for deciding whether or not the mounted electrode 
has been removed from the portable blood sugar value-measuring apparatus before the second 
55 predetermined period of time terminates and then deciding whether or not the selected electrode has 
been mounted thereon before a predetermined period of time terminates; allowing the second clocking 
process to be switched to the writing process when it is decided that the mounted electrode has been 
removed from the portable blood sugar value-measuring apparatus and not been mounted thereon 



17 



EP 0 651 250 A2 



before a predetermined period of time terminates; and suspending writing of the data of a currently 
measured blood sugar value to the storing means when it is decided that the mounted electrode has 
been removed from the portable blood sugar value-measuring apparatus and the selected electrode 
has been mounted thereon before a predetermined period of time terminates. 

5 

8. The data managing method as claimed in claim 4 or 7, wherein the deciding process comprises a 
liquid kind-classifying data-output process (S7) for deciding whether or not the mounted electrode has 
been removed from the portable blood sugar value-measuring apparatus and then whether or not the 
selected electrode has been mounted thereon; outputting liquid kind-classifying data to the storing 

w means when it is decided that the mounted electrode has been removed from the portable blood sugar 
value-measuring apparatus and the selected electrode has been mounted thereon; and allowing the 
process of measuring the blood sugar value of the liquid to be executed, and when the blood sugar 
value-measuring function is selected in the preparatory process, the liquid kind-classifying data-output 
process is executed. 

9. A portable blood sugar value-measuring apparatus, having no operation button, for selecting a function 
to be executed based on one of electrodes each of which has resistance value executing a function, the 
apparatus having an electrode detection means (3,52) for detecting whether or not one of the 
electrodes removable therefrom has been mounted thereon, thus outputting a mounting detection 

20 signal; and a signal output means (53,54), connected with an output side of the electrode detection 
means, for outputting a function selection signal based on a resistance value of the electrode mounted 
on the portable blood sugar value-measuring apparatus, the apparatus comprising: 

a storing means (70) for storing data of measured blood sugar values obtained by executing a 
blood sugar value-measuring function selected based on the resistance value of the mounted electrode; 

25 a preparatory means (50a), connected with the output side of the electrode detection means and an 

output side of the signal output means, for setting the portable blood sugar value-measuring apparatus 
to an operation start state when the electrode detection means detects that the electrode has been 
mounted on the portable blood sugar value-measuring apparatus and selecting the function to be 
executed based on the function selection signal; 

30 a first clocking means (50b) connected with an output side of the preparatory means, for clocking a 

first predetermined period of time from a point when the function is selected by the preparatory means; 

a deciding means (50c), connected with an output side of the first clocking means, the output side 
of the electrode detection means, and the output side of the signal output means, for deciding whether 
or not the mounting detection signal and the function selection signal have been supplied while 

35 clocking the first predetermined period of time is being executed; and 

a read-out means (50d), connected with the output side of the deciding means and an output side 
of the storing means, for reading out the data of the measured blood sugar values stored in the storing 
means from a point when the first predetermined period of time has terminated and outputting the data 
of the measured blood sugar values when the first predetermined period of time has terminated without 

40 the deciding means deciding whether or not the function selection signal has been supplied. 

10. The portable blood sugar value-measuring apparatus as claimed in claim 9, further comprising: 

a data erasing means (50j), an input side of which is connected with the electrode detecting means 
and the read-out means and an output side of which is connected with the storing means, the data 

45 erasing means deciding whether or not the mounted electrode has been removed from the portable 
blood sugar value-measuring apparatus before the data of the measured blood sugar values read out 
from the storing means is outputted from the read-out means and then whether or not the selected 
electrode has been mounted thereon before a predetermined period of time terminates, based on the 
mounting detection signal outputted from the electrode detecting means; and erasing the data of the 

so measured blood sugar values stored in the storing means when it is decided that the mounted 
electrode has been removed from the portable blood sugar value-measuring apparatus before the data 
of the measured blood sugar values read out from the storing means is outputted from the read-out 
. means and the selected electrode has been mounted thereon before the predetermined period of time 
terminates. 

55 

11. The portable blood sugar value-measuring apparatus as claimed in claim 9, further comprising: 

a blood sugar value-measuring means (50e), connected with the output side of the deciding means, 
for executing an operation of measuring the blood sugar value of to-be-measured liquid which has 



18 



EP 0 651 250 A2 



dropped to the blood sugar value-measuring electrode corresponding to a measuring function after 
mounted on the portable blood sugar value-measuring apparatus and then the liquid dropped on the 
electrode; and 

a writing means (50h), an input side of which is connected with the blood sugar value-measuring 
5 means and the deciding means and an output side of which is connected with the storing means, for 
writing the data of the measured blood sugar values outputted from the blood sugar value-measuring 
means and liquid kind-classifying data outputted from the deciding means to the storing means. 

12. The portable blood sugar value-measuring apparatus as claimed in claim 9 or 10, further comprising a 
/o dropping deciding means (50k), an input side of which is connected with the read-out means and the 
signal output means and an output side of which is connected with the blood sugar value-measuring 
means and the read-out means, the dropping deciding means deciding whether or not the function 
selection signal has been supplied before the data of all the measured blood sugar values read out 
from the storing means is outputted from the read-out means; allowing an operation of measuring the 
75 blood sugar value of the liquid which has dropped to the mounted electrode to be executed when it is 
decided that the function selection signal has been supplied; and continuing the output of the data of 
the measured blood sugar values to the read-out means when it is decided that the function selection 
signal has not been supplied. 

20 13. The portable blood sugar value-measuring apparatus as claimed in claim 11, further comprising: 

a second clocking means (50f), connected with an output side of the blood sugar value-measuring 
means, for clocking a second predetermined period of time from a point when the operation of 
measuring the blood sugar value terminates; and 

a writing permission/nonpermission deciding means (50g), an input side of which is connected with 

25 the second clocking means and the electrode detecting means and an output side of which is 
connected with the writing means, the writing permission/nonpermission deciding means deciding 
whether or not the blood sugar value-measuring electrode has been removed from the blood sugar 
value-measuring apparatus before the second predetermined period of time terminates and then 
whether or not the blood sugar value-measuring electrode has been mounted thereon before a 

30 predetermined period of time terminates, based on the mounting detection signal outputted from the 
electrode detecting means; outputting the data of the blood sugar values measured by the blood sugar 
value-measuring operation to the writing means when it is decided that the blood sugar value- 
measuring electrode has been removed from the portable blood sugar value-measuring apparatus 
before the second predetermined period of time terminates and the selected electrode has not been 

35 mounted thereon before the predetermined period of time terminates; and then suspending writing of 
the data of a currently measured blood sugar value to the storing means when it is decided that the 
blood sugar value-measuring electrode has been removed from the blood sugar value-measuring 
apparatus and the selected electrode has been mounted thereon. 

40 14. The portable blood sugar value-measuring apparatus as claimed in any one of claims 9, 10, and 12, 
further comprising: 

a display means (2) for displaying information visually; and 

a predetermined value-display means (50i), an input side of which is connected with the prepara- 
tory means and an output side of which is connected with the display means, for causing the display 
45 means to display a predetermined value based on a resistance value of an electrode for measuring the 
resistance value mounted on the portable blood sugar value-measuring apparatus, when a function of 
measuring the resistance value is selected by the preparatory means. 

15. The portable blood sugar value-measuring apparatus as claimed in claim 11 or 13, wherein when the 
so blood sugar value-measuring electrode is mounted on the portable blood sugar value-measuring 
apparatus, the deciding means decides whether or not the blood sugar value-measuring electrode has 
been removed from the portable blood sugar vaiue-measuring apparatus and then whether or not the 
blood sugar value-measuring electrode has been mounted thereon again based on the mounting 
detection signal; and outputting the liquid kind-classifying data to the writing means when it is decided 
55 that the blood sugar value-measuring electrode has been removed from the portable blood sugar value- 
measuring apparatus and mounted thereon again before the blood sugar value-measuring means is 
actuated. 



19 



EP 0 651 250 A2 



Fig.1 



S4 



(INSERTION , N 

COMPLETION ( ELECTRODE IS MOUNTED j SI 

" SOUND) " ' " 



USTING ELECTRODE 

pis" 

Q 



ALL DISPLAYS ARE TURNED 
ON FOR TWO SECONDS 



BATTERY VOLTAGE IS DETECTED 
— I 



NO 



i brat i on electrode! 
"yes" 



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S3 



NO 



CONTROL LIQUID 
CAN BE USED 



NEXT MEASUREMENT NUMBER 

AND "F" NUMBER ARE 
ALTERNATELY DISPLAYED 



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20 



EP 0 651 250 A2 



Fig.2 



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TEMPERATURE T1 IS MEASURED 




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S16 





ERROR IS 


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DISPLAYED 



MEASURED / CALCULATED 



S18 




MEASUREMENT RESULT 


IS DISPLAYED 











(MEASUREMENT 
COMPLETION SOUND) 



21 



EP 0 651 250 A2 




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27 



EP 0 651 250 A2 



Fig. 9 



50 



53,54 

I 



SIGNAL 

OUTPUT 

MEANS 



3,52 



ELECTRODE 
DETECTING 
CIRCUIT 



-50a 



PREPARATORY 
PORTION 



»50*i | 



PREDETERMINED 
VALUE - DISPLAY 
PORTION 



FIRST CLOCKING 
PORTION 



-50b 



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PORTION 



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BLOOD SUGAR 
VALUE - MEASURING 
PORTION 



50f 



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PORTION 



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DISPLAY 



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PORTION 



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PORTION 



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PORTION 



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PORTION 



28 



EP 0 651 250 A2 



Fig. 1 1 




29 



EP 0 651 250 A2 



Fig. 12 




30 



EP 0 651 250 A2 



Fig. 13 




31 



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